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Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

Primary Purpose

Acute Graft Versus Host Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pentostatin for injection
Sponsored by
Astex Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Graft Versus Host Disease focused on measuring acute graft versus host disease, aGVHD, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cord blood transplant, pentostatin, Nipent, deoxycoformycin

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion: Patients 6 months of age with grade 2 GVHD that is steroid-refractory Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC Time post stem cell infusion < 100 days Written informed consent Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2) Exclusion: Post-transplant lymphoproliferative disease Uncontrolled infection Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study ATG within the previous 14 days Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days

Sites / Locations

  • MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 2, 2002
Last Updated
October 21, 2020
Sponsor
Astex Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00032773
Brief Title
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
Official Title
A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
January 30, 2002 (Actual)
Primary Completion Date
November 3, 2005 (Actual)
Study Completion Date
November 3, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astex Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Graft Versus Host Disease
Keywords
acute graft versus host disease, aGVHD, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cord blood transplant, pentostatin, Nipent, deoxycoformycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pentostatin for injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Patients 6 months of age with grade 2 GVHD that is steroid-refractory Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC Time post stem cell infusion < 100 days Written informed consent Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2) Exclusion: Post-transplant lymphoproliferative disease Uncontrolled infection Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study ATG within the previous 14 days Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

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